BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 24554829 · Received March 10, 2026

    Report

    Report Number
    3003741676-2026-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 10, 2026
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    DXN
    PMA / PMN Number
    K091737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. CUSTOMER FEEDBACK RECEIVED A USER COMPLAINT ABOUT A BATTERY EXPLODING INSIDE THE MACHINE. WE HOPE TO OBTAIN THE BATTERY, MACHINE, RELATED DAMAGE PICTURES OR USAGE METHOD AND ENVIRONMENT FOR FURTHER ANALYSIS. THE CUSTOMER FEEDBACK IS BEING TRACKED, BUT THERE IS NO PROGRESS FOR THE TIME BEING. 2. RISK ANALYSIS WAS PERFORMED ON THIS MODEL OF DEVICE, COVERING DESIGN SELF-INSPECTION, RISK DOCUMENT REVIEW, AND DESIGN VERIFICATION INSPECTION. BASED ON THE ANALYSIS RESULTS AND THE EXISTING INFORMATION FROM CUSTOMER COMPLAINTS, IT IS CONFIRMED THAT THE PROBABILITY OF BATTERY EXPLOSION IN THE MAIN UNIT OF THE SPHYGMOMANOMETER IS EXTREMELY LOW. 3. NO SERIOUS INJURIES WERE REPORTED IN THIS INCIDENT, BUT THERE IS A POTENTIAL RISK OF ADVERSE HEALTH EFFECTS IF IT OCCURS AGAIN, SO THIS REPORT IS EVALUATED AND SUBMITTED. 4. IF ADDITIONAL USER INFORMATION OR OTHER RELEVANT EVIDENCE IS OBTAINED IN THE FUTURE, THE INVESTIGATION WILL CONTINUE AND THE FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BATTERIES EXPLODED INSIDE THE MACHINE AND THE SPRING PART HAS FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618354 MEDLINE System, measurement, blood-pressure, non-invasive DXN ANDON HEALTH CO., LTD. KD-5031M 43320070001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown